Capnostream
®
20
p
Portable Bedside Monitor
Capnograph/Pulse Oximeter
Operator’s Manual
PN: 012194C
0482
Notice: Purchase of this product confers no express or implied license under any Oridion Medical 1987 Ltd.
patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987
Ltd.
Possession or purchase of this device does not convey an express or implied license to use the device with
unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of
one or more of the patents relating to this device.
Oridion
®
, Microstream
®
, FilterLine, Smart CapnoLine
®
, CapnoLine
®
, Smart BiteBloc™, NIV Line™,
CapnoBloc™, Smart CapnoLine Guardian™, SARA™, Integrated Pulmonary Index™, Capnostream
®
20
p
,
Microcap
®
, Microcap
®
Plus, and VitalCap
®
are trademarks or registered trademarks of Oridion Medical 1987
Ltd.
Nellcor Puritan Bennett LLC is a Covidien company.
The following are trademarks of Nellcor Puritan Bennett LLC: Oxiband™; Durasensor™; OxiCliq
®
; Dura-Y
™
;
Max-Fast™ and O
XIMAX™.
The capnography component of this product is covered by: US Patents: www.covidien.com/patents.
The pulse oximetry component of this product is covered by: US Patents: www.covidien.com/patents.
Exemptions
Oridion Medical 1987 Ltd.'s liability under this warranty does not include any transportation damage or other
charges or liability for direct, indirect or consequential damages or delay resulting from improper use or
application of the product or the substitution upon it of parts or accessories not approved by Oridion Medical
1987 Ltd.
All information in this manual is believed to be correct. Oridion Medical 1987 Ltd. shall not be liable for errors
contained herein with the performance or use of this manual.
Copyright © 2014 Oridion Medical 1987 Ltd. All rights reserved.
Portable Bedside Capnograph/Pulse Oximeter
1
Table of Contents
Table of Contents 1
List of Figures 8
List of Tables 9
Oridion Medical 1987 Ltd. ("Oridion Medical") - Warranty for
Oridion Monitors 10
Safety Information 11
Warnings ....................................................................................................................... 11
General ....................................................................................................................................... 11
MRI Scanning ............................................................................................................................. 12
Monitor Use with Defibrillators ................................................................................................... 12
Alarms ........................................................................................................................................ 12
Fire Hazard................................................................................................................................. 12
Electrical ..................................................................................................................................... 13
Electro-magnetic Interference .................................................................................................... 13
Definitions ..................................................................................................................... 14
Chapter 1 15
About this Manual 15
Overview ....................................................................................................................... 15
Intended Use ................................................................................................................. 15
Specific Indications for Use ........................................................................................... 16
Who Should Read This Manual ..................................................................................... 16
Contacting Technical Support ....................................................................................... 16
Symbols ........................................................................................................................ 16
Chapter 2 19
Technology Overview 19
Introduction ................................................................................................................... 19
Features ........................................................................................................................ 19
Technology Overview .................................................................................................... 19
What is Capnography? .............................................................................................................. 19
What is Pulse Oximetry? ............................................................................................................ 20
Chapter 3 21
The Capnostream Monitor 21
Unpacking and Inspection ............................................................................................. 21
Installing the Battery Pack ............................................................................................. 22
Testing the Battery and AC Connections................................................................................... 23
Handling the Battery Pack ......................................................................................................... 23
2
Portable Bedside Capnograph/Pulse Oximeter
Storing the Battery ..................................................................................................................... 24
Disposing of the Battery ............................................................................................................. 24
Battery and Power Usage .......................................................................................................... 24
Mounting the Monitor..................................................................................................... 25
Setting up Periodic Maintenance ................................................................................... 25
Accessories ................................................................................................................... 25
Available Accessories ................................................................................................................ 25
Monitor Mounting Plate .............................................................................................................. 26
Printer Paper .............................................................................................................................. 26
Buttons, Indicators and Connections ............................................................................. 26
Monitor Front View ..................................................................................................................... 27
Front Panel Control Buttons .......................................................................................... 28
Monitor Rear Panel .................................................................................................................... 29
Monitor Left and Right Views ..................................................................................................... 30
Turning on the Monitor .................................................................................................. 30
Standard Sections of the Display Screen ...................................................................... 31
Home Screen Standard Display ................................................................................................. 32
Home Screen Numeric Display .................................................................................................. 36
Terminating Operation of the Monitor ............................................................................ 37
Screen Navigation ......................................................................................................... 37
Configuration Changes .............................................................................................................. 38
Setting Date, Time, Language, and Other Options ....................................................... 38
Screen Timeouts ........................................................................................................... 39
Screen Timeouts ........................................................................................................................ 39
Capnostream
®
20
p
: Operational Check Sheet ................................................................ 40
Chapter 4 43
Using the Capnostream Monitor 43
Preparing the Monitor for a Patient ............................................................................... 43
Setting the Patient Type ............................................................................................................. 43
Using Patient Cases and Patient ID Numbers ............................................................... 44
Entering Patient Events ................................................................................................. 46
Changing the Alarm and Pulse Volumes ....................................................................... 46
Alarm Volume ............................................................................................................................. 46
Pulse Tone Volume .................................................................................................................... 47
Alarm Volume Default Options ................................................................................................... 47
Alarm Delay ................................................................................................................... 48
Use of Scavenging System ........................................................................................... 48
Turning the Pump Off for Suction or Lavage ................................................................. 48
Demo Mode ................................................................................................................... 49
Monitor Screen Menu Reference Chart ......................................................................... 49
Portable Bedside Capnograph/Pulse Oximeter
3
Chapter 5 53
Capnography with the Capnostream Monitor 53
Microstream
®
EtCO
2
Consumables ............................................................................... 53
Basic Principles .......................................................................................................................... 53
Microstream
®
EtCO
2
Consumables ........................................................................................... 54
Connecting a FilterLine ................................................................................................. 54
CO
2
Data Displayed by the Capnostream Monitor ........................................................ 54
Adjustable CO
2
Parameters .......................................................................................... 55
Monitoring CO
2
during MRI Scanning ........................................................................... 56
Chapter 6 57
Pulse Oximetry with the Capnostream Monitor 57
Nellcor SpO
2
Sensors ................................................................................................... 57
Data Update Period, Data Averaging, and Signal Processing .................................................. 58
Selecting Nellcor SpO
2
Sensors ................................................................................................ 58
Performance Considerations ..................................................................................................... 59
Connecting an SpO
2
Sensor to the Monitor................................................................... 60
SpO
2
Data Displayed by the Capnostream Monitor ...................................................... 60
Adjustable SpO
2
Parameters......................................................................................... 62
SPO
2
Alarm Limit Message ........................................................................................... 62
Chapter 7 63
Integrated Pulmonary Index™ 63
Introduction ................................................................................................................... 63
Warnings ....................................................................................................................... 64
IPI Display ..................................................................................................................... 64
IPI Options .................................................................................................................... 64
Chapter 8 65
Apneas per Hour and the Oxygen Desaturation Index 65
Introduction ................................................................................................................... 65
Apneas per Hour ........................................................................................................... 65
The Capnostream Apneas per Hour .......................................................................................... 65
A/hr Visual Alert ......................................................................................................................... 66
Oxygen Desaturation Index (ODI) ................................................................................. 66
Apnea and O2 Desaturation Report .............................................................................. 66
Monitoring with A/hr and ODI ........................................................................................ 66
Smart A/hr and ODI Home Screen Display ................................................................... 67
A/hr and ODI Option ...................................................................................................... 67
A/hr and ODI Demo Mode ............................................................................................. 67
4
Portable Bedside Capnograph/Pulse Oximeter
Chapter 9 69
Alarms and Messages 69
Introduction ................................................................................................................... 69
Alarm Display ................................................................................................................ 70
Message Priorities ......................................................................................................... 72
Alarm Delay ................................................................................................................... 72
Types of Alarms ............................................................................................................ 72
High Priority Alarms ................................................................................................................... 73
Medium Priority Alarms .............................................................................................................. 74
Advisories ................................................................................................................................... 75
Silent Advisories ......................................................................................................................... 75
Parameter Standby Mode ............................................................................................. 76
Alarm Silence ................................................................................................................ 78
Changing Alarm Limits .................................................................................................. 79
Testing Alarm Settings .................................................................................................. 80
SpO
2
Alarms and SatSeconds ...................................................................................... 80
SatSeconds Alarm Display ........................................................................................................ 81
Alarm Limits - Factory Defaults ..................................................................................... 82
Chapter 10 83
Using Trends 83
Introduction ................................................................................................................... 83
The Trend Display Screens ........................................................................................... 84
Graphical Trend Display Screen ................................................................................... 84
Graphical Trend Display............................................................................................................. 84
Using SCROLL and ZOOM ........................................................................................................ 85
Tabular Trend Display Screen ....................................................................................... 87
Choosing Trend Parameters ......................................................................................... 89
Important Notes Regarding Trend Reports ................................................................... 89
Specific Events as seen in Trend Data.......................................................................... 89
Using the Graphical Trend Screen for Monitoring Patients ........................................... 89
Printing the Trend Data ................................................................................................. 89
Clearing Trend Memory ................................................................................................. 90
Configuring Trends ........................................................................................................ 90
Event Marking Mode .................................................................................................................. 91
Trend Graphical Display............................................................................................................. 91
Trend Increment Display ............................................................................................................ 91
Chapter 11 93
Reports 93
Apnea and O
2
Desaturation Report ............................................................................... 93
Printed Report Options .................................................................................................. 97
Printed Reports ............................................................................................................. 97
Portable Bedside Capnograph/Pulse Oximeter
5
Sample Reports........................................................................................................... 101
Sample Case Reports .............................................................................................................. 101
Sample Trend Reports ............................................................................................................. 102
Chapter 12 103
Downloading Patient Data 103
Introduction ................................................................................................................. 103
Data Transfer via the USB Data Port .......................................................................... 103
USB File Naming Convention .................................................................................................. 106
Examples .................................................................................................................................. 106
USB Error Messages ............................................................................................................... 107
Reading Patient Data from Saved Capnostream Files ............................................................ 107
Data Transfer via the RS-232 Port .............................................................................. 107
Analog Data Output with Capnostream ....................................................................... 107
Nurse Call Operation ................................................................................................... 107
Types of Nurse Call Systems ...................................................................................... 108
The Nurse Call Cable ............................................................................................................... 108
Activating Nurse Call ................................................................................................................ 109
Testing Nurse Call .................................................................................................................... 109
Operation with Hospital Patient Data Systems ............................................................ 110
Operation with Nuvon VEGA Systems ........................................................................ 110
Chapter 13 111
Maintenance and Troubleshooting 111
Introduction ................................................................................................................. 111
Determining Monitor Service Hours ............................................................................. 111
CO
2
Calibration ........................................................................................................... 112
CO
2
Calibration Check ................................................................................................ 113
Calibration Check Procedure ................................................................................................... 113
Maintenance ................................................................................................................ 114
Replacing the Fuses .................................................................................................... 114
Replacing the Printer Paper Roll ................................................................................. 115
Cleaning ...................................................................................................................... 115
Troubleshooting........................................................................................................... 116
Electrical ................................................................................................................................... 116
CO
2
Problems .......................................................................................................................... 116
SpO
2
Sensor ............................................................................................................................ 117
Printer ....................................................................................................................................... 117
Nurse Call ................................................................................................................................. 118
CO
2
Calibration ........................................................................................................................ 118
Returning the Monitor .................................................................................................. 118
Technical Assistance ................................................................................................... 118
6
Portable Bedside Capnograph/Pulse Oximeter
Appendix 1 119
Institutional Settings 119
Institutional Defaults .................................................................................................... 119
Changing Institutional Defaults .................................................................................... 119
Resetting to Factory Defaults ...................................................................................... 120
Uploading or Downloading Institutional Defaults ......................................................... 120
Changing Monitor Settings .......................................................................................... 121
Alarm Limits .............................................................................................................................. 121
Alarm Delay .............................................................................................................................. 123
Trend Settings .......................................................................................................................... 123
Changing Parameters Order on the Trend Display ................................................................. 123
Events ...................................................................................................................................... 124
How to Change Event Defaults ................................................................................................ 124
Monitor Settings ....................................................................................................................... 124
CO
2
Parameters ....................................................................................................................... 126
SpO
2
Parameters ..................................................................................................................... 126
Appendix 2 127
Specifications 127
Power Supply .............................................................................................................. 127
Battery ......................................................................................................................... 127
Controls ....................................................................................................................... 127
Display ........................................................................................................................ 128
Microstream
®
Capnography ........................................................................................ 128
Nellcor Oximax
®
Pulse Oximetry ................................................................................. 129
Alarms ......................................................................................................................... 129
Outputs ........................................................................................................................ 129
Analog Output .......................................................................................................................... 129
Nurse Call ................................................................................................................................. 130
RS-232 ..................................................................................................................................... 131
USB .......................................................................................................................................... 131
Internal Thermal Printer (optional) ............................................................................... 131
General Characteristics ............................................................................................... 132
Equipment Classification ............................................................................................. 132
Compliance ................................................................................................................. 132
Electromagnetic Immunity ........................................................................................................ 132
Appendix 3 137
Microstream EtCO
2
Consumables 137
Microstream EtCO
2
Consumables............................................................................... 137
8
Portable Bedside Capnograph/Pulse Oximeter
List of Figures
Figure 1 - Installing the Battery Pack ................................................................................................... 22
Figure 2 - Battery Pack Close-up ......................................................................................................... 22
Figure 3 - Menu Bar with Battery Charge Level ................................................................................... 23
Figure 4 - Monitor Bottom View ............................................................................................................ 25
Figure 5 - Capnostream Front View ..................................................................................................... 27
Figure 6 - Front Panel Control Buttons ................................................................................................ 28
Figure 7 - Capnostream Rear View ...................................................................................................... 29
Figure 8 - Capnostream Left View ........................................................................................................ 30
Figure 9 - Salutation Screen ................................................................................................................. 31
Figure 10 - Typical Home Screen ......................................................................................................... 32
Figure 11 - Typical Home Screen when A/hr and ODI are not Available ............................................ 33
Figure 12 - Standard Home Screen without IPI Option ....................................................................... 34
Figure 13 - Header Area ....................................................................................................................... 34
Figure 14 - Typical Numeric Home Screen .......................................................................................... 36
Figure 15 - System Setup Screen ........................................................................................................ 39
Figure 16 - Menu Bar ............................................................................................................................ 47
Figure 17 - Alarm Volume Selection..................................................................................................... 47
Figure 18 - Pulse Tone Volume Selection ............................................................................................ 47
Figure 19 - Scavenger System Connection Point ................................................................................ 48
Figure 20 - Screen Menu Reference Chart when A/hr and ODI are available .................................... 50
Figure 21 - Screen Menu Reference Chart when A/hr and ODI are not available .............................. 51
Figure 22 - CO
2
Data on the Capnostream Monitor ............................................................................. 54
Figure 23 - CO
2
Section of Numeric Home Screen ............................................................................. 55
Figure 24 - SpO
2
Data on the Capnostream Monitor - Standard Screen ............................................ 61
Figure 25 - SpO
2
Data on the Capnostream Monitor – Standard Screen with IPI Disabled ............... 61
Figure 26 - SpO
2
Section of Numeric Home Screen ............................................................................ 62
Figure 27 - IPI Trend Graph ................................................................................................................. 63
Figure 28 - Capnostream Alarm Review Screen ................................................................................. 71
Figure 29 - Example Showing Alarms .................................................................................................. 73
Figure 30 - Alarm Limits Screen ........................................................................................................... 79
Figure 31 - Graphical Trend Display .................................................................................................... 84
Figure 32 - Scroll mode in the Graphical Trend ................................................................................... 86
Figure 33 - Tabular Trend Display ........................................................................................................ 87
Figure 34 - Trend Memory Message .................................................................................................... 90
Figure 35 - Apnea and Desat Report Screen ....................................................................................... 95
Figure 36 - Apnea and Desat Printed Report ....................................................................................... 96
Figure 37 - Print Screen ....................................................................................................................... 98
Figure 38 - Sample Case Reports Printout ........................................................................................ 101
Figure 39 - Printed Trend Reports ...................................................................................................... 102
Figure 40 - Typical Flash Memory Device .......................................................................................... 104
Figure 41 - USB Icon .......................................................................................................................... 105
Figure 42 - Stereo Phono Plug for Nurse Call.................................................................................... 108
Figure 43 - Connection Point for Nurse Call ...................................................................................... 109
Figure 44 - Service Screen ................................................................................................................. 112
Figure 45 - Insert Paper Roll into printer ............................................................................................ 115
Figure 46 - Institutional Defaults Screen ............................................................................................ 120
Figure 47 - Software Support Screen ................................................................................................. 121
Figure 48 - Institutional Defaults Alarm Limits Screen ....................................................................... 122
Figure 49 - Institutional Defaults: Monitor .......................................................................................... 125
Portable Bedside Capnograph/Pulse Oximeter
9
List of Tables
Table 1 - Symbols that Appear on the Monitor .................................................................................... 16
Table 2 - Capnostream Accessories .................................................................................................... 25
Table 3 - Printer Paper Specifications .................................................................................................. 26
Table 4 - Capnostream Front View ...................................................................................................... 28
Table 5 - Capnostream Rear View ....................................................................................................... 29
Table 6 - Capnostream Left View ......................................................................................................... 30
Table 7 - Header Section ..................................................................................................................... 34
Table 8 - Event Markings ..................................................................................................................... 46
Table 9 - Audio Alarm Volume ............................................................................................................. 47
Table 10 - Adjustable CO
2
Parameters ................................................................................................ 56
Table 11 - Nellcor SpO
2
Sensors ......................................................................................................... 58
Table 12 - Adjustable SpO
2
Parameters .............................................................................................. 62
Table 13 - Adjustable IPI Options ........................................................................................................ 64
Table 14 - Alarm Indications ................................................................................................................. 69
Table 15 - High Priority Alarms ............................................................................................................ 73
Table 16 - Medium Priority Alarms ....................................................................................................... 74
Table 17 - Advisories ............................................................................................................................ 75
Table 18 - Silent Advisories .................................................................................................................. 75
Table 19 - Message and Alarm Status during Different Parameter Standby Situations ..................... 78
Table 20 - Tabular Display Example .................................................................................................... 88
Table 21 - Detailed Tabular Display Example ...................................................................................... 88
Table 22 - Monitor Parameters............................................................................................................. 90
Table 23 - Printed Reports – Parameters ............................................................................................ 98
Table 24 - Data Transfer Types ......................................................................................................... 103
Table 25 - Select Data Output Type ................................................................................................... 105
Table 26 - File Naming Conventions .................................................................................................. 106
Table 27 - Nurse Call Specs .............................................................................................................. 108
Table 28 - Nurse Call Indicators ......................................................................................................... 109
Table 29 - Factory Default Alarm/Indicator Limits .............................................................................. 122
Table 30 - Factory Default and Optional Alarm Delay Settings ......................................................... 123
Table 31 - Factory Default and Optional Trend Settings ................................................................... 123
Table 32 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions ........................ 133
Table 33 - Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ......................... 133
Table 34 - Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the Monitor .......................................................................... 135
10
Portable Bedside Capnograph/Pulse Oximeter
Oridion Medical 1987 Ltd. ("Oridion Medical") -
Warranty for Oridion Monitors
THIS LIMITED WARRANTY applies to any patient monitor manufactured by Oridion Medical 1987 Ltd.
(“Oridion”), (“Products”). Subject to the limitations herein, Oridion warrants that Products, when delivered by
Oridion or its authorized distributor, for two (2) years following the delivery date, but no more than 27 months
following the date of production, will be free from defects in material and workmanship and will substantially
conform to published Oridion specifications for the respective Products and in effect at the time of manufacture.
This limited warranty excludes (i) Products purchased through unauthorized third parties; (ii) Products that have
been subject to misuse, mishandling, accident, alteration, neglect, unauthorized repair or installation; and (iii)
Products that have been used with accessory consumable products other than Oridion’s FilterLine
®
products.
Furthermore, this limited warranty shall not apply to the use of Products in an application or environment that is not
within Oridion specifications or in the event of any act, error, neglect or default of Customer. Oridion at its sole
discretion will replace or repair the damaged Products. Customer may not return Products without first obtaining a
customer return material authorization (RMA) number from Oridion or one of the Authorized Service centers and a
copy of the Product purchase invoice.
Disclaimer
USER MAY USE THE PARAMETERS (INCLUDING ANY AND ALL REFERENCES TO CO2, SPO2,
CURRENT INTEGRATED PULMONARY INDEX™ AND FUTURE AND RELATED INDICES AND
CONFIGURATIONS AND SIGNAL ALARM NOTIFICATIONS) WHICH APPEAR ON ORIDION'S PATIENT
MONITORING DEVICES AND/OR ORIDION’S COMMUNICATION PROTOCOL AND/OR ANY OUTPUT
IN REPORTS DOWNLOADED FROM ORIDION'S PATIENT MONITORING DEVICES TO PRINTERS OR
USB MEMORY STICKS OR APPROVED SYSTEMS ("DATA") SOLELY AND EXCLUSIVELY FOR THE
PURPOSE OF PATIENT CARE. USER ACKNOWLEDGES THAT DATA TRANSMITTED FROM
ORIDION'S PATIENT MONITORING DEVICES MAY NOT BE TRANSFERRED, INTERFACED,
EXCHANGED OR OTHERWISE TRANSMITTED AND THAT ORIDION ACCEPTS NO RESPONSIBILITY
WHATSOEVER FOR THE ACCURACY OR COMPLETENESS OF DATA THAT HAS BEEN
TRANSFERRED, INTERFACED, EXCHANGED OR OTHERWISE TRANSMITTED. USER FURTHER
ACKNOWLEDGES THAT IT MAY NOT SELL, LICENSE OR OTHERWISE COMMERCIALIZE THE DATA,
IN WHOLE OR IN PART. ANY OTHER USE OF THE DATA OR INTERFACE WITH OTHER SYSTEMS,
WHETHER BY USER OR ANY PARTY ON ITS BEHALF, SHALL BE SUBJECT TO A SEPARATE
LICENSING ARRANGEMENT WITH ORIDION INCORPORATING, BUT NOT LIMITED TO,
COMMERCIAL TERMS TO BE NEGOTIATED IN GOOD FAITH.
USER ACKNOWLEDGES AND UNDERSTANDS THAT THE DATA IS PROVIDED “AS-IS” AND THAT
ORIDION DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. ORIDION WILL NOT BE LIABLE
FOR ANY INJURIES OR DAMAGES TO ANY PERSONS OR TANGIBLE OR INTANGIBLE PROPERTY
RESULTING FROM ANY CAUSE WHATSOEVER. ORIDION DISCLAIMS ANY AND ALL LIABILITY
FOR DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR OTHER SIMILAR DAMAGES
REGARDLESS OF THE FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING
NEGLIGENCE), STRICT PRODUCT LIABILITY OR ANY OTHER LEGAL OR EQUITABLE THEORY,
EVEN IF ORIDION HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSSES OR DAMAGES.
Portable Bedside Capnograph/Pulse Oximeter
11
Do not touch this field - it is invisible and does not appear in the
final document
Safety Information
Warnings
Definitions
To use the Capnostream
®
20
P
monitor (henceforth referred to as Capnostream) correctly and safely, carefully
read this operator’s manual and the Directions for Use that accompany Microstream
®
etCO
2
consumables
(FilterLines
®
, henceforth referred to as FilterLines) and the SpO
2
sensors. Use of the monitor requires full
understanding and strict observance of these instructions, the precautionary information in boldface type, and
the specifications.
Warnings
General
WARNING: If uncertain about the accuracy of any measurement, first check the patient’s vital signs by
alternate means, and then make sure the monitor is functioning correctly.
WARNING: The device should not be used as an apnea monitor.
WARNING: The device should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter
to completely understand the patient's condition.
WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall
on the patient.
WARNING: Carefully route patient cabling (SpO
2
sensor and FilterLine) to reduce the possibility of
patient entanglement or strangulation.
WARNING: Do not lift the monitor by the SpO
2
sensor cable or FilterLine, as they could disconnect
from the monitor, causing the monitor to fall on the patient.
WARNING: The monitor should not be used adjacent to or stacked with other equipment; if adjacent or
stacked use is necessary, the monitor shall be observed to verify normal operation in the
configuration in which it will be used.
WARNING: To ensure accurate performance and prevent device failure, do not expose the monitor to
extreme moisture, such as rain.
WARNING: The use of accessories, transducers, sensors and cables other than those specified may result
in increased emission and/or decreased immunity of the equipment and/or system.
WARNING: Re-use of single-use accessories could pose a cross-contamination risk to the patient or
damage the functioning of the monitor.
WARNING: CO
2
readings, respiratory rate, pulse oximetry readings, and pulse signals can be affected by
sensor application errors, certain ambient environmental conditions, and certain patient
conditions.
WARNING: The monitor is a prescription device and is to be operated by qualified healthcare personnel
only.
WARNING: No modification of this equipment is allowed.
Warnings
12
Portable Bedside Capnograph/Pulse Oximeter
WARNING: If calibration does not take place as instructed in the relevant service manual, the monitor
may be out of calibration. A monitor that is out of calibration may provide inaccurate
results.
Note: Devices connected to the monitor must be medical grade only.
Note: The accurate display of the following parameters is required in order to fill the essential performance of
the device: Carbon dioxide levels in expired breath (CO
2
) and respiration rate when monitoring with
capnography, and arterial oxygen saturation of blood (SpO
2
) and Pulse rate when monitoring with pulse
oximetry. If the patient is being monitored with both functions, all of these parameters will be displayed.
MRI Scanning
WARNING: Do not use oximetry sensors during magnetic resonance imaging (MRI) scanning.
Conducted current could cause burns. The sensors may affect the MRI image, and the MRI
unit may affect the accuracy of oximetry measurements.
WARNING: Do not use the FilterLine H Set Infant/Neonatal during magnetic resonance imaging (MRI)
scanning. Using the FilterLine H Set Infant/Neonatal during MRI scanning could harm the
patient.
CAUTION: During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor
is used outside the MRI suite, etCO
2
monitoring can be implemented using the FilterLine
XL. (Refer to Monitoring CO2 during MRI Scanning on page 56.
CAUTION: Use of a CO
2
sampling line with H in its name (indicating that it is for use in humidified
environments) during MRI scanning may cause interference. The use of non-H sampling
lines is advised. For a list of H sampling lines, see Microstream EtCO2 Consumables on
page 137.
Monitor Use with Defibrillators
WARNING: All cables and tubing, including SpO
2
sensors and CO
2
sampling lines, should be kept clear
of the defibrillator and its electrodes, and should not run between, adjacent to, or
overlapping the electrodes and the electrode wires, in order to reduce potential interference
between the monitor and defibrillation equipment.
WARNING: All SpO
2
sensors must be completely intact and undamaged, in order to enable use of a
defibrillator with the monitor.
Alarms
WARNING: Do not silence the audible alarm if patient safety may be compromised.
WARNING: Always respond immediately to a system alarm since the patient may not be monitored
during certain alarm conditions.
WARNING: Before each use, verify that the alarm limits are appropriate for the patient being monitored.
WARNING: Check the audible alarm silence duration before temporarily silencing the audible alarms.
WARNING: Auditory alarm signal sound pressure levels which are less than ambient sound levels can
impede operator recognition of alarm conditions.
CAUTION: Setting alarm limits to extreme values may impair the alarm system’s effectiveness.
Fire Hazard
WARNING: When using the monitor with anesthetics, nitrous oxide or high concentrations of oxygen,
connect the gas outlets to a scavenger system.
WARNING: The monitor is not suitable for use in the presence of flammable anesthetic mixture with air,
oxygen or nitrous oxide.
Warnings
Portable Bedside Capnograph/Pulse Oximeter
13
WARNING: The FilterLine may ignite in the presence of O
2
when directly exposed to laser, ESU
devices, or high heat. When performing head and neck procedures involving laser,
electrosurgical devices or high heat, use with caution to prevent flammability of the
FilterLine or surrounding surgical drapes.
Electrical
WARNING: To protect against electric shock hazard, the monitor’s cover is to be removed only by
qualified service personnel. There are no user-serviceable parts inside.
WARNING: To ensure patient electrical isolation, connect only to other equipment with circuits that are
electrically isolated.
WARNING: Connect the device only to a three-wire, grounded, hospital grade receptacle. The three-
conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire
receptacle is not available, a qualified electrician must install one in accordance with the
governing electrical code. Do not under any circumstances remove the grounding connector
from the power plug. Do not use extension cords or adapters of any type. The power cord
and plug must be intact and undamaged. To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with protective earth.
WARNING: Ensure that the monitor is positioned so that its mains plug is accessible for immediate
disconnection from supply mains, when needed.
WARNING: If there is any doubt about the integrity of the protective earth conductor arrangement,
operate the device on internal battery power until the AC power supply protective
conductor is fully functional.
WARNING: Do not connect to an electrical outlet controlled by a wall switch or a dimmer.
WARNING: Measure the device's leakage current whenever an external device is connected to the serial
port. Leakage current must not exceed 100 microamperes.
WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective grounding.
WARNING: Whenever the equipotential ground at the back of the device (reference Figure 7 -
Capnostream Rear View on page 29) is to be used, the user must connect to the pin in a way
which will ensure that accidental disconnection is avoided.
WARNING: In a facility which provides detachable potential equalization conductors, the Equipotential
ground at the back of the device (reference Figure 7 - Capnostream Rear View on page 29)
may be used for optional connection between the Capnostream and the potential
equalization busbar of the electrical installation. The Equipotential ground at the back of the
device should not be used for a protective earth connection.
WARNING: Always connect power cord to the device first, and then plug the power cord into the wall
outlet.
CAUTION: Electrical installation of the room or the building in which the monitor is to be used must
comply with regulations specified by the country in which the equipment is to be used.
CAUTION: Keep power cord, plug and socket clear in case an urgent power supply disconnection is
required.
Electro-magnetic Interference
This device has been tested and found to comply with the requirements for medical devices according to the
standard EN60601-1-2. This standard is designed to provide reasonable protection against harmful interference
in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical
noise in healthcare environments (for example: cellular phones, mobile two–way radios, electrical appliances),
Definitions
14
Portable Bedside Capnograph/Pulse Oximeter
it is possible that high levels of such interference due to close proximity or strength of a source may result in
disruption of performance of this device.
WARNING: Operating high frequency electrosurgical equipment in the vicinity of the monitor can
produce interference in the monitor and cause incorrect measurements.
WARNING: Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the function
of the monitor may be disturbed.
Definitions
Note: A Note is inserted to point out procedures or conditions which may otherwise be misinterpreted or
overlooked and to clarify apparently contradictory or confusing situations.
Caution: A Caution is inserted to call attention to a procedure which, if not followed exactly, can lead to
damage or destruction of the equipment.
Warning: A Warning is inserted to call attention to dangerous or hazardous conditions inherent to the
operation, cleaning, and maintenance of the equipment which may result in personal injury or death of the
operator or patient.
Portable Bedside Capnograph/Pulse Oximeter
15
Do not touch this field - it is invisible and does not appear in the
final document
Chapter 1
About this Manual
Overview
Intended Use
Specific Indications for Use
Who Should Read This Manual
Contacting Technical Support
Symbols
Overview
This manual provides directions for setting up and operating the Capnostream monitor.
The Capnostream is a portable bedside monitor that continuously monitors a patient’s:
• End tidal carbon dioxide (etCO
2
) - level of carbon dioxide in exhaled breath.
• Respiratory rate (RR).
• Fractional inspired carbon dioxide (FiCO
2
) - level of carbon dioxide present during inhalation.
• Oxygen saturation (SpO
2
).
• Pulse rate (PR).
The device also provides an Integrated Pulmonary Index™ (henceforth referred to as IPI) value, which is a
numerical value that integrates four major parameters measured by Capnostream in order to provide a simple
indication of the patient’s ventilatory status. The integrated parameters are etCO
2
, RR, SpO
2
, and PR. Only
these four parameters are used to calculate IPI; other parameters are not taken into account.
In addition, the device provides the Apneas per Hour (A/hr) and an Oxygen Desaturation Index (ODI), used to
help in the identification and quantification of apnea and oxygen desaturation events for patients over age 22, as
follows:
• A/hr: a count of the number of pauses in breathing (of at least 10 seconds) which the patient experienced,
either over the past hour (on the Home screen) or average pauses per hour over a period of time (on the
Apnea and O
2
Desaturation screen).
• ODI: the number of times that the SpO
2
value dropped 4% or more from baseline and returned to baseline
in 240 seconds or less, either in the last hour (on the Home screen) or average pauses per hour over a
period of time (on the Apnea and O
2
Desaturation screen).
The A/hr and ODI indices are not available in all locations. In order to equip your device with the A/hr and ODI
feature, contact Capnographyinfo@covidien.com
.
Intended Use
The Capnostream
®
20
p
combined capnograph/pulse oximeter monitor and its accessories are intended to provide
professionally trained health care providers with continuous, non-invasive measurement and monitoring of
carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-
invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO
2
) and pulse rate. It is intended
for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital
transport environments.
Capnostream
®
20p is to be operated by qualified healthcare personnel only.
Specific Indications for Use
16
Portable Bedside Capnograph/Pulse Oximeter
The Capnostream
®
20
p
monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based
on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and
pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of
1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the
patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Specific Indications for Use
An additional indication of the monitor is to provide information to help in the identification of apnea and
oxygen desaturation events in adult patients (age 22 and up) in hospital ICU and general floor environments,
through the reporting of these events and calculation of the associated apnea per hour (A/hr) and oxygen
desaturation index (ODI).
Who Should Read This Manual
This manual should be read by:
• Health Care Professionals who will be using Capnostream.
• Equipment managers responsible for ensuring that equipment conforms to institutional policies.
• Researchers or laboratory personnel who will be downloading patient data.
• Technical experts who will be connecting Capnostream to a computer via the RS-232 interface.
WARNING: In the United States, federal law restricts this device to sale by or on the order of a
physician.
Contacting Technical Support
For any technical issue involving the Capnostream monitor, please contact Oridion Technical Support, as
follows:
North America: Tel: 1-888-ORIDION (674-3466), Fax: (781) 453-2722; Outside North America:
Tel: + (972) 2-589-9104, Fax: + (972) 2-582-8868; E-mail: Capnographytechnicalsupport@covidien.com
.
Symbols
The following symbols appear on the body of the monitor.
Table 1 - Symbols that Appear on the Monitor
Symbol Description
Monitor ON/OFF button
AC power ON indicator
UNIT ON indicator
Event selection
Patient Admit/Discharge
Symbols
Portable Bedside Capnograph/Pulse Oximeter
17
Symbol Description
Pump Off
Temporarily silence alarms
Type BF Defibrillator Proof Protection
General warning sign
Gas inlet
Gas outlet
Equipotential ground
USB flash memory connection port
CE Mark
For prescription use only
Directive on waste electrical and electronic
equipment
Follow instructions for use
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